Donepezil Tarbis 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Donepezil Tarbis 5 mg film-coated tablets EFG

Donepezil hydrochloride monohydrate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Donepezil Tarbis is and what it is used for
2. What you need to know before taking Donepezil Tarbis
3. How to take Donepezil Tarbis
4. Possible side effects
5. How to store Donepezil Tarbis
6. Contents of the pack and other information

1. What Donepezilo Tarbis is and what it is used for

Donepezilo Tarbis belongs to a group of medicines known as specific and reversible inhibitors of acetylcholinesterase, the predominant cholinesterase in the brain.

It is used for the symptomatic treatment of mild to moderately severe Alzheimer's disease.

2. What you need to know before taking Donepezilo Tarbis

Do not take Donepezilo Tarbis

• If you are allergic to donepezil or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to other medicines containing piperidine derivatives.
• If you are pregnant or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Donepezilo Tarbis

• Before starting treatment with Donepezilo Tarbis 5 mg film-coated tablets, you must inform your doctor if you have or have a history of stomach ulcer, heart disease, seizures, asthma, chronic lung disease, or difficulty urinating.

• If you require surgery under general anesthesia, you must inform your doctor that you are taking Donepezilo Tarbis 5 mg film-coated tablets.

• The use of Donepezilo Tarbis 5 mg film-coated tablets is not recommended in children.

• You should avoid taking Donepezilo Tarbis 5 mg film-coated tablets together with other acetylcholinesterase inhibitors or other agonists or antagonists of the cholinergic system.

• If you have vascular dementia (loss of brain function due to a series of small strokes).

• If you have a heart condition (such as irregular or very slow heartbeat, heart failure, myocardial infarction).

• If you have a heart condition called <> or a history of abnormal heart rhythms known as torsade de pointes, or if anyone in your family has <>.

• If you have low levels of magnesium or potassium in your blood.

Taking Donepezilo Tarbis with other medicines

It is especially important that you inform your doctor if you are taking any of the following types of medicines:

• Medicines for heart rhythm problems, for example amiodarone or sotalol
• Medicines for depression, for example citalopram, escitalopram, amitriptyline, fluoxetine
• Medicines for psychosis, e.g., pimozide, sertindole, or ziprasidone
• Medicines for bacterial infections, for example, clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• Antifungal medicines, such as ketoconazole
• Other medicines for Alzheimer's disease, for example, galantamine
• Painkillers or arthritis treatment, for example, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or sodium diclofenac
• Anticholinergic medicines, e.g., tolterodine
• Antibiotics, for example, erythromycin or rifampicin
• Antifungal medicine, e.g., ketoconazole
• Antidepressants, e.g., fluoxetine
• Anticonvulsants, e.g., phenytoin, carbamazepine
• Medications for heart disease, for example quinidine, beta-blockers (propranolol and atenolol)
• Muscle relaxants, e.g., diazepam, succinylcholine
• General anesthetics
• Over-the-counter medicines, for example, herbal remedies

The individual effect of donepezil cannot be predicted; therefore, the effect of treatment should be regularly evaluated by your doctor.

Taking Donepezilo Tarbis with food, drinks, and alcohol

Taking donepezil with alcohol may reduce the absorption of this medicine. You should avoid drinking alcohol while being treated with donepezil.

Children:

The use of donepezil is not recommended in children.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Donepezilo Tarbis if you are pregnant.

Do not take Donepezilo Tarbis if you are breastfeeding your child.

Driving and using machines:

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Donepezil may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.

Donepezilo Tarbis contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Donepezil Tarbis

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. The recommended normal dose is described below.

Donepezil is administered orally.

You should take donepezil once daily, orally with a glass of water at night, immediately before going to bed.

If you experience abnormal dreams, nightmares or difficulty sleeping (see section 4), your doctor may recommend that you take donepezil in the morning.

Your dose may vary depending on how long you have been taking the medicine and on your doctor's advice. Usually treatment starts with one 5 mg tablet taken once daily with some water at night. After one month of treatment, your doctor may instruct you to increase the dose to 10 mg once daily at night. The maximum recommended dose is 10 mg daily.

Both you and your caregivers should be aware of your doctor's instructions.

If you have mild or moderate hepatic impairment (liver disease) or renal impairment (kidney disease), you may follow a dosing regimen similar to the one described above.

If you take more Donepezil Tarbis than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the medicine and the amount ingested.

At high doses (overdose), adverse effects may worsen (see section 4 Possible side effects). In particular, nausea, vomiting, salivation, sweating, slow heartbeat, low blood pressure, difficulty breathing, collapse, seizures and muscle weakness may occur.

If you forget to take Donepezil Tarbis:

If you forget to take a dose, take the missed dose as soon as possible. Unless it is time for the next dose.

Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Donepezil Tarbis 5 mg film-coated tablets may produce adverse effects, although not everyone experiences them. The estimated frequency of occurrence is as follows:

Serious adverse effects:

You must immediately inform your doctor if you notice any of the following serious adverse effects, as you may require urgent medical treatment.

• Fever with muscle rigidity, sweating, or decreased level of consciousness (symptoms of a disorder known as "neuroleptic malignant syndrome").
• Muscle weakness, sensitivity, or pain, particularly if accompanied by feeling unwell, fever, or dark-coloured urine. This may be due to abnormal muscle breakdown, which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis).

Very common adverse effects (may affect more than 1 in 10 patients):

• Diarrhoea
• Nausea
• Headache

Common adverse effects (may affect between 1 and 10 in 100 patients):

• Cold symptoms
• Loss of appetite
• Hallucinations, agitation, aggressive behaviour
• Fainting, dizziness, difficulty sleeping
• Vomiting, abdominal discomfort
• Urinary incontinence
• Rash, itching
• Muscle cramps
• Fatigue, pain
• Accidents

Uncommon adverse effects (may affect between 1 and 10 in 1,000 patients):

• Seizures
• Slowing of the heart rate
• Gastrointestinal bleeding, stomach and duodenal ulcers (a part of the intestine)
• Increase in a type of enzyme (muscle creatine kinase) in the blood

Rare adverse effects (may affect between 1 and 10 in 10,000 patients):

• Extrapyramidal symptoms (such as tremor or stiffness of the hands or legs)
• Cardiac conduction disturbances
• Liver function abnormalities, including hepatitis

Adverse effects with unknown frequency (cannot be estimated from available data):

• Changes in heart activity that may be seen on an electrocardiogram (ECG), known as "QT interval prolongation".
• Rapid and irregular heartbeat, fainting, which may be symptoms of a potentially life-threatening disorder known as torsade de pointes.
• Increased libido, hypersexuality.
• Pisa syndrome (a condition involving involuntary muscle contractions with abnormal sideways bending of the body and head).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Donepezil Tarbis

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Donepezil Tarbis 5 mg film-coated tablets

The active substance is donepezil hydrochloride monohydrate. Each film-coated tablet contains 5 mg of donepezil hydrochloride, equivalent to 4.56 mg of donepezil base.

The other components are:

Tablet core

monohydrate lactose
microcrystalline cellulose
corn starch
magnesium stearate

Coating

polyvinyl alcohol
titanium dioxide (E171)
macrogol 3350
talc

Appearance of the medicine and contents of the pack

Donepezil Tarbis 5 mg tablets are white, round, biconvex, film-coated tablets marked with 'DZ5'.

Each pack contains 28 or 50 tablets (clinical pack) in aluminum-PVC blisters or in a PE bottle.

Donepezil Tarbis is also available as 10 mg film-coated tablets in packs of 28 and 50 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.
Gran Vía Carlos III, 94
Barcelona (Spain)

Manufacturer:

Actavis Limited
BLB016 Bulebel Industrial Estate
Zejtun, ZTN 3000
Malta

Date of the most recent revision of this leaflet: October 2022

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”